NCT03395704

A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis

A Phase 2, Multi-Center, Randomized, Placebo Controlled, Single-Blind Study With LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: La Jolla Pharmaceutical Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 2 multicenter, randomized, placebo controlled, single-blind study. The primary objective of the study is to compare the effect of weekly dosing of LJPC-401 (synthetic human hepcidin) versus placebo on transferrin saturation (TSAT) in an adult hereditary hemochromatosis patient population.

Conditions

• Hereditary Hemochromatosis

Interventions

Type	Name	Description
DRUG	LJPC-401	LJPC-401 subcutaneous injection, up to 20 mg weekly for 16 weeks. The minimum weekly dose will be 5 mg and the maximum weekly dose of LJPC-401 will be 20 mg.
DRUG	Placebo	0.9% Sodium Chloride Injection, USP, or equivalent

Timeline

• Start date: 2017-11-29
• Primary completion: 2019-10-28
• Completion: 2019-10-28
• First posted: 2018-01-10
• Last updated: 2022-06-09
• Results posted: 2022-06-09

Locations

31 sites across 4 countries: United States, Australia, France, United Kingdom

Regulatory

• FDA-regulated drug study